Colibri System— 510(k) K193138

Substantially Equivalent

Copan Wasp Srl

FDA 510(k) clearance K193138 for Colibri System, Substantially Equivalent on 2021-12-27. Applicant: Copan Wasp Srl.

Clearance details

Applicant: Copan Wasp Srl
Product code: Code QQV
Advisory panel: Microbiology
Date received: 2019-11-13
Decision date: 2021-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brescia, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code QQV

product code QQV

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.